search
Back to results

Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

Primary Purpose

Familial Hypercholesterolemia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
APL180
APL180
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Familial Hypercholesterolemia focused on measuring Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed presence of familial hypercholesterolemia
  • Women must be sterilized or post-menopausal

Exclusion Criteria:

  • Smoking an average of greater than 10 cigarettes per day
  • History of cardiac events
  • Very low or high body weight
  • Treatment with fibrates or niacin
  • High blood triglyceride levels

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in forearm blood flow during each treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2008
    Last Updated
    September 22, 2016
    Sponsor
    Novartis Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00751608
    Brief Title
    Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients
    Official Title
    A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Familial Hypercholesterolemia
    Keywords
    Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    APL180
    Intervention Type
    Drug
    Intervention Name(s)
    APL180
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in forearm blood flow during each treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed presence of familial hypercholesterolemia Women must be sterilized or post-menopausal Exclusion Criteria: Smoking an average of greater than 10 cigarettes per day History of cardiac events Very low or high body weight Treatment with fibrates or niacin High blood triglyceride levels Other protocol-defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis Investigator Site
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

    We'll reach out to this number within 24 hrs